Venlafaxine With or Without Zolpidem in Treating Hot Flashes and Associated Sleep Disorders in Women With Breast Cancer OR at High Risk for Developing Breast Cancer

NCT00084669 | Completed

• 3 other identifiers: CDR0000365502MGH-DFCI-02311DFCI-02311
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Venlafaxine may be effective in relieving hot flashes caused by hormone therapy. Giving venlafaxine with zolpidem (a sleeping pill) may improve sleep and quality of life in women who are receiving hormone therapy for treatment or prevention of breast cancer. PURPOSE: This randomized clinical trial is studying giving venlafaxine together with zolpidem to see how well it works compared to venlafaxine alone in relieving hot flashes and associated sleep disorders in women who are receiving hormone therapy to treat or prevent breast cancer.

Conditions

Breast Cancer; Hot Flashes; Sleep Disorders

Keywords

hot flashes; sleep disorders; ductal breast carcinoma in situ; breast cancer in situ; lobular breast carcinoma in situ; lobular breast carcinoma; recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Sleep improvement by biologic data and actigraphy data at the end of study treatment

Secondary Outcomes (1)

• Quality of life by BDI, QOLI, PSI, NCCTG symptom diary, PSQI, MOS SF-36 at the end of study treatment

Interventions

venlafaxine DRUG

zolpidem tartrate DRUG

management of therapy complications PROCEDURE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * At increased risk of developing breast cancer, meeting 1 of the following criteria: * Diagnosis of 1 of the following: * Ductal carcinoma in situ * Invasive breast cancer * Lobular carcinoma in situ * Atypical ductal or lobular hyperplasia * Lobular carcinoma * Candidate for breast cancer risk reduction for any of the following: * Predisposing mutation in a breast cancer susceptibility gene * Prior chest radiotherapy for Hodgkin's disease * Gail model score \> 1.67% over 5 years * Experiencing daytime and nocturnal hot flushes at least 14 times per week within the past 2 weeks * Experiencing sleep disturbance, characterized by the presence of all of the following for ≥ 1 month: * ≥ 3 awakenings per night occurring ≥ 3 nights per week * Insomnia impedes daytime function * Hot flushes are the primary cause of insomnia (determined at baseline visit) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 to 65 Sex * Female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 6 months Hematopoietic * Not specified Hepatic * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No clinically significant cardiac disease * No uncontrolled hypertension within the past 3 months, defined as the following: * Diastolic blood pressure \> 95 mm Hg on \> 1 occasion * Systolic blood pressure \> 160 mm Hg on \> 1 occasion Pulmonary * No clinically significant respiratory disease Psychiatric * Beck depression inventory score ≤ 15 * No active panic or depressive disorder within the past month * No lifetime history of bipolar or psychotic disorder * No active substance-use disorders, including alcohol and benzodiazepines, within the past year * No suicidal or homicidal ideation * No hypomania or mania Other * No prior adverse reaction to venlafaxine or zolpidem * None of the following sleep disorders within the past 6 months: * Sleep apnea * Narcolepsy * Periodic limb movement disturbance * No abuse or misuse of study medication * No daytime sedation that interferes with ability to function * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 3 months since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * More than 1 month since prior regular use (\> 25% of the time) of oral, transdermal, or injection preparations of androgens, estrogens, or progestins * Vaginal suppositories and creams allowed * No concurrent regular use of oral, transdermal, or injection preparations of androgens, estrogens, or progestins Radiotherapy * See Disease Characteristics * More than 3 months since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics Other * More than 1 month since prior regular use (\> 25% of the time) of any of the following: * Hypnotic agents (e.g., benzodiazepines, zolpidem, zaleplon, trazodone, or diphenhydramine) * Clonidine * More than 1 month since prior antidepressants or other medications that are known to influence mood \> 25% of the time (no serotonin-reuptake inhibitors \[SRI\] stratum only) * Concurrent SRI required provided they were initiated ≥ 1 month ago at or above the minimum dose, including any of the following (concurrent SRI stratum only): * Fluoxetine * Paroxetine * Paroxetine CR * Sertraline * Citalopram * S-citalopram * Venlafaxine * Fluvoxamine * No concurrent warfarin * No concurrent hypnotic agents, clonidine, or antidepressants, or other medications known to influence sleep, or mood

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115-6084, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes; Sleep Wake Disorders; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Carcinoma, Lobular

Interventions

Venlafaxine Hydrochloride; Zolpidem

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hadine Joffe, MD, MSC

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: May 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2010
• Last Updated: April 28, 2010

Record last verified: 2010-04

Locations

US (2)